Documentation Technician

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

Responsibilities:

• Perform a detailed and careful review of incoming inspection records for completeness, accuracy and compliance with cGMP, GDP, ISO13485 and BD-Humacao procedures.
• Prepare reports and forms as directed to summarize review findings.
• Consult incoming supervisor and appropriate resources (ie. SQE) questions related to finding found during record review.
• Perform a variety of administrative duties including but not limited to communication via email, answering phones and filing documents.

Qualifications Requirements/Knowledge/Education/Skills:

• Medical device background preferred, working knowledge of applicable medical device regulations (21CFR820, ISO 13485:2016)
• Bachelor degree
• Basic math knowledge (conversion between fractions and decimals, arithmetic with fractions)

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.

Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.